MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI MODULAR; MODULAR TULIP

Catalog Number	39-MT-0401
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was performed by on (b)(6)2023, utilizing the reform ti modular screw system.The scrub tech connected the reform ti modular polyaxial tulip assembly (39-mt-0401) to the 65mm reform ti modular non-cannulated screw (39-sb-xxxx), loaded the assembled screw/tulip on the driver and handed it to the surgeon.When the surgeon attempted to implant the screw, the tulip detached from the screw.The screw was taken to the back table and reassembled on a different screw and subsequently implanted successfully.There was no delay to the procedure or patient injury.
Additional Manufacturer Narrative
H3 device evaluation - without a product return, no product evaluation can be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.Without lot numbers, review of device history records and lot specific complaint history is not possible.Two-year complaint history review (7.27.2021-7.27.2023) found this to be the only complaint of this nature for both of the part numbers reported.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2023-00038 / 00039).

• Brand Name: REFORM TI MODULAR
• Common Device Name: MODULAR TULIP
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 17568836
• Report Number: 3005739886-2023-00038
• Device Sequence Number: 15124275
• Product Code: KWP
• UDI-Device Identifier: 00840019932622
• UDI-Public: 00840019932622
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 39-MT-0401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown